Schwartzberg Eyal, Berkovitch Matitiahu, Dil Nahlieli Dorit, Nathan Joseph, Gorelik Einat
Pharmaceutical & Enforcement Divisions, Ministry of Health, 39 Yirmiyahu St., Jerusalem, Israel.
School of Pharmacy, Ben-Gurion University of the Negev, Beer sheeba, Israel.
Isr J Health Policy Res. 2017 Aug 1;6(1):29. doi: 10.1186/s13584-017-0154-3.
Due to the limited safety data available at the time that a new medication is first marketed, it is essential to continue the collection and monitoring of safety data about adverse drug reactions (ADRs) during the medication's life cycle. This activity, known as pharmacovigilance (PV), is performed worldwide by the pharmaceutical industry as well as by regulatory agencies. In 2012, the Israeli Ministry of Health (MOH) established a Pharmacovigilance and Drug Information Department. The Department is tasked with identifying, monitoring, and initiating activities aimed at minimizing risks associated with medication utilization. To enable this, the MOH has devised procedures for PV and promoted extensive legislation in this area that require marketing authorization holders (MAHs) and medical institutions in Israel to report ADRs and new safety information to the MOH. A computerized database was created to support the reporting process. The objective of this article is to characterize the PV tools and activities implemented in Israel.
Since September 2014, The Israeli Pharmacovigilance and Drug Information Department receives ICSRs at a central computerized database developed for this purpose. The data were analyzed by Department personnel and ICSRs were characterized according to their seriousness, source, categories of drugs involved, and the reporting format. Additionally, the Department reviewed signals detected from ADR reports and from other sources and assessed the resulting regulatory actions.
An analysis of the Individual Case Safety Reports (ICSRs) submitted to the MOH's ADRs central database reveals that during the review period, a total of 16,409 ICSRs were received by the Department and 850 signals were identified, resulting in the following PV activities: inquiry and enhanced follow-up (430, 50.6%), prescriber's and patient's leaflets updates (204, 24%), recall of products/batches (6, 0.7%), alerts for health care professionals (63, 7.4%). Eighty five (10%) of the signals required a comprehensive investigation involving external specialist and 1 (0.1%) resulted in initiation of epidemiologic study. Additionally, in 2015 the Department incorporated comprehensive framework for risk minimization of marketed medicinal products, also known as risk management plans (RMPs).
As practiced by other health authorities, the Israeli MOH effectively implemented various PV tools to ensure the safety of the Israeli health consumer.
由于新药首次上市时可用的安全数据有限，在药物的整个生命周期内持续收集和监测药物不良反应（ADR）的安全数据至关重要。这项被称为药物警戒（PV）的活动在全球范围内由制药行业和监管机构开展。2012年，以色列卫生部（MOH）设立了药物警戒和药物信息部。该部门的任务是识别、监测并开展旨在将药物使用相关风险降至最低的活动。为实现这一目标，卫生部制定了药物警戒程序，并推动了该领域的广泛立法，要求以色列的上市许可持有人（MAH）和医疗机构向卫生部报告药物不良反应和新的安全信息。创建了一个计算机化数据库以支持报告流程。本文的目的是描述以色列实施的药物警戒工具和活动。
自2014年9月起，以色列药物警戒和药物信息部在为此目的开发的中央计算机化数据库中接收个例安全报告（ICSR）。部门人员对数据进行分析，并根据ICSR的严重程度、来源、涉及的药物类别和报告格式进行特征描述。此外，该部门审查了从药物不良反应报告和其他来源检测到的信号，并评估了由此产生的监管行动。
对提交给卫生部药物不良反应中央数据库的个例安全报告（ICSR）的分析显示，在审查期间，该部门共收到16409份ICSR，识别出850个信号，从而开展了以下药物警戒活动：询问和加强随访（430例，50.6%）、更新处方者和患者说明书（204例，24%）、召回产品/批次（6例，0.7%）、向医护人员发出警报（63例，7.4%）。85个（10%）信号需要涉及外部专家的全面调查，1个（0.1%）导致启动流行病学研究。此外，2015年该部门纳入了已上市药品风险最小化的综合框架，也称为风险管理计划（RMP）。
正如其他卫生当局所践行的那样，以色列卫生部有效地实施了各种药物警戒工具，以确保以色列卫生消费者的安全。
